Leqvio Side Effects: What to Expect and When to Call Your Doctor

Leqvio (inclisiran) has a generally favorable safety profile — most patients tolerate it very well. In clinical trials involving over 1,800 patients, the safety profile was described as largely comparable to placebo, with the exception of injection site reactions. Here's everything you need to know about Leqvio side effects before starting treatment.

Common Side Effects of Leqvio (Occurring in ≥3% of Patients)

The FDA-identified adverse reactions from three placebo-controlled clinical trials (1,833 patients) that occurred in at least 3% of Leqvio patients and more frequently than placebo were:

• Injection site reaction — including pain, redness, rash, swelling, bruising, or warmth at the injection site. This is the most reported side effect and is usually mild to moderate.
• Arthralgia — joint pain or stiffness. This was reported in a meaningful percentage of patients compared to placebo.
• Bronchitis — chest cold/lower respiratory infection. Patients with asthma or COPD should discuss this with their doctor.

Other Reported Side Effects

Additional side effects reported in clinical studies (not required to be ≥3% vs. placebo) include:

• Urinary tract infection (UTI) — Leqvio may increase the risk of UTIs. Contact your doctor if you experience burning, urgency, or frequent urination.
• Diarrhea
• Pain in extremity (limb pain)
• Dyspnea (shortness of breath)
• Elevated liver transaminases (ALT elevated in up to 19.7% of patients, AST in up to 17.2%) — these are lab findings, not typically symptomatic. Your doctor may monitor liver enzymes.

Serious Side Effects: When to Seek Emergency Care

The most serious potential side effect of Leqvio is a severe hypersensitivity reaction, including anaphylaxis and angioedema. Although rare, these reactions have been reported. Seek emergency medical attention immediately if you experience:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue, or throat
• Severe skin itching with a red rash or raised bumps (hives)
• Dizziness or fainting
• Sudden drop in blood pressure

Leqvio is contraindicated in patients with a prior serious hypersensitivity reaction (anaphylaxis or angioedema) to inclisiran or any ingredient in the formulation.

What About Muscle Pain? Does Leqvio Cause Muscle Side Effects Like Statins?

No. Unlike statins, Leqvio does not cause myalgia (muscle pain) or myopathy. It works through a completely different mechanism — targeting PCSK9 messenger RNA in the liver — and does not affect muscle tissue. This is one of the reasons Leqvio is particularly valuable for patients who are statin-intolerant.

Does Leqvio Cause Weight Gain?

Weight gain is not a reported side effect of Leqvio in clinical trials. It also has not been reported with other PCSK9 inhibitors such as Repatha or Praluent.

Pregnancy, Breastfeeding, and Other Contraindications

Leqvio should not be used during pregnancy, as it may harm an unborn baby. There is no established safety data for use in pregnant women. If you become pregnant during treatment, stop Leqvio immediately and contact your doctor. It is unknown whether Leqvio passes into breast milk.

Leqvio has not been established as safe or effective in patients under 18 years of age.

Long-Term Safety Data

The ORION-8 open-label extension trial (3,274 patients) provided long-term safety data consistent with the Phase 3 trial results. No new or unexpected safety signals emerged with extended use. The majority of adverse events in clinical trials were mild to moderate in severity.

For information about how Leqvio interacts with other medications, see our guide on Leqvio drug interactions.

Having trouble getting your Leqvio injection scheduled? Read how to find Leqvio in stock near you.